The Effect of Body Posture on Intraocular Pressure in Progressive Glaucoma

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ClinicalTrials.gov Identifier: NCT01351779

Recruitment Status
: Unknown

Verified May 2011 by University of Toronto. Recruitment status was: Recruiting

Glaucoma is a condition where the optic nerve (the nerve responsible for sight) shows progressive damage with characteristic loss of visual field. Glaucoma is very commonly associated with raised pressure in the eye (intraocular pressure [IOP]). IOP has been shown to increase when lying down in normal subjects as well as patients with glaucoma. It is possible that this effect can make glaucoma worse. This study is designed to investigate the effect of body posture (particularly when sleeping) on the IOP fluctuation in the eye. Each patient will be required to attend for 2 separate 24 hour visits. On one visit the patient will be required to sleep flat and on the other visit at a 30° head up sleeping position. During this time the patient will be required to wear a soft contact lens (SENSIMED Triggerfish®) which has a special sensor on it that monitors the IOP continuously. The IOP measurements are wirelessly transmitted to a recorder.

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Ages Eligible for Study:

18 Years to 85 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Glaucoma clinic patients

Criteria

Inclusion Criteria:

signed informed consent

diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) that is progressing based on recent or recurrent optic disc hemorrhage

age 18-85 years

not more than 4 diopters of spherical equivalent or 2 diopters of cylinder equivalent in study eye

stable anti-glaucoma treatment for 4 weeks before first session

for women of childbearing potential, adequate contraception

Exclusion Criteria:

unwilling or unable to sleep in a flat or 30 degrees head up position

ocular surgery in previous 3 months

corneal or conjunctival abnormality

wear of full frame metallic glasses during monitoring session

severe dry eye

secondary forms of glaucoma

allergy to corneal anaesthesia

patients with contraindications for contact lens wear

pregnancy and lactation

patients unable to understand the character and individual consequences of the investigation